1. Field of the Invention
The subject invention is directed to devices for regulating blood flow in the venous system, and more particularly, to the design and production of artificial valve devices designed to regulate the flow of blood in human vessels.
2. Description of Related Art
Artificial venous valves offer numerous possibilities that can be very attractive to clinicians and patients. Benefits of such designs include, the possibility of improved functional stability and life while reducing size and bulk of the valve, which offers opportunities for interventional, less traumatic procedures for valve placement. In spite of the existence of a great number of artificial valve designs, very few of them have managed to pass through clinical trials and make it to the clinical arena.
Today's use of artificial valves is limited to relatively bulky mechanical valves or tissue based valves. The reason for this is that small and compact valves, suitable for interventional applications, require the use of thin metal frames and ultra thin polymer parts joined together, to meet the harsh requirements of a multimillion cycle application in blood flow. Herein is the main problem of percutaneously inserted valves—their mechanical designs, historically, have not proven to be as robust as that of bulkier valves, and have been prone to biocompatibility, long term stability, wear and fatigue issues.
Such conventional methods and systems have generally been considered satisfactory for their intended purpose. However, there is still a need in the art for artificial valves that allow for improved fatigue resistance. There also remains a need in the art for such artificial valves that are easy to make and use. The present invention provides a solution for these problems.